Otc - Active Ingredient
Active ingredient(s)
Menthol 4.0%
Relief Flex Patch
FDA Label NDC 87379-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Beone Co., Ltd. for the product Relief Flex (NDC 87379-010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Topical analgesic
Indications & Usage
Use(s)
■ temporarily relieves pain associated with minor:
muscle aches
joint pain
backache
strains and sprains
Warnings
Warnings
■ For external use only
■ Do not use
on wounds or damaged skin
with a heating pad
if you are allergic to menthol or any of the ingredients in this product
■ When using this product
avoid contact with eyes or mucous membranes
do not bandage tightly
use only as directed
keep away from excessive heat
■ Stop use and ask a doctor if rash occurs
■ Keep out of reach of children, If product is swallowed, get medical help or contact a Poison Control Center right away.
Otc - Keep Out Of Reach Of Children
■ Keep out of reach of children, If product is swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
■ adults and children 12 years and older:
apply to affected area not more than 1 to 2 times daily
rub in thoroughly until absorbed
■ children under 12 years of age:
ask a doctor
Other Safety Information
Other Information
■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light
Otc - Questions
Questions
■ www.kbeone.com
Inactive Ingredient
Inactive ingredients
Mineral Oil, Hydrogenated Dicyclopentadiene/Isopentene/Isoprene/Styrene Copolymer, Hydrogenated Styrene/Butadiene Copolymer, Silicate, Ginger, Soil mineral, Styrene Copolymer, Hydrogenated Styrene, Butadiene/Isoprene Copolymer, 1,2-Hexandiol, Lavender Oil, Chamomile Oil, Nitric oxide, Cordyceps Sinensis Extract, Gardenia, MSM
* Please review the disclaimer below.
